Nonconformance Management Software

REDUCE CYCLE TIMES AND ASSOCIATED RISKS.

With integrated Nonconformance Management, you can improve the quality of your medical devices, and reduce non-conformance cycle times and the risks associated with your device.

FIGURE OUT WHAT THE REAL ISSUE IS

Today, many companies do not have a defined system for processing or finding the root cause of a nonconformance issue. Many of the steps companies go through are unfounded, a bit ad hoc and may not really be worth the eort. These issues have been treated as singular events and reacted to.

For example, if there is a defective part, the easy path has been to send the part back to the supplier. End of story. But what if there were other parts from the same supplier that were defective? Until now, that root cause has gone unnoticed. Now you have a workflow to address the nonconformance issue and to escalate the right defects to a CAPA at the right time.

GAIN IMPORTANT VISIBILITY

By centralizing and connecting more of the pieces together, you will have more visibility into root cause of nonconformances and the ability to take the next appropriate action. For example, by easily capturing defect details and sources, you can assign them to immediate action tasks that allow you to take decisive actions such as quarantine, scrap, return to vendor, etc.

By having more visibility into nonconformance issues and all the other things they may be linked to, you will have a much better picture and indicator of the health of your suppliers and your manufacturing process.

MAKE THE PROCESS EASIER

Assign nonconformance-related tasks to your team and track everyone’s progress towards due dates. Manage tasks, follow-ups, communications, and any actions that result from audit findings. Access your nonconformance artifacts and provide them to the auditor in a couple of clicks with absolute confidence nothing has changed.

TIE EVERYTHING TOGETHER

Ensure full traceability and auditability throughout since you can easily see what was changed, why it was changed, when it changed, who changed it, and what was impacted as a result of a nonconformance.

By tying everything together, you know if this has happened before, if there are issues with suppliers at a higher level, and what is impacted by this event. Now you know and you can see it so you can do something about it

August 3, 2017

“Positive Greenlight Guru Experience”

Real time reviewing and publishing of quality documents. GUI of website makes it very easy to navigate without any hassle.